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The purpose of this study is to assess the safety and practicality, feasibility and efficacy of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans population, as delivered by routine clinicians at the Veterans Affairs.
Full description
The proposed research will evaluate the safety and practicality, feasibility, and efficacy of a relatively simple, manual guided integrated cognitive behavioral therapy (ICBT). ICBT (a revised edition of what was formerly called cognitive behavioral therapy for posttraumatic stress disorder [CBT for PTSD]) has been designed and developed for delivery by counselors employed in community addiction treatment programs and offered in conjunction with standard community addiction treatment. The investigators have completed a Stage I Safety & Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing ICBT versus a control condition) in community addiction treatment and for all studies found that ICBT was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to conduct a Stage I study of ICBT among Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans within the Veterans Affairs treatment setting. The investigators will modify the existing ICBT for testing in a VA setting, and use a combined individual and group modality.
There are 3 specific aims for this study, and hypotheses for each aim:
Aim 1: To test the feasibility of ICBT with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at 3- and 6-month follow-up (Stage I Phase I: Safety and practicality testing; Feasibility Study).
Aim 2: To revise the ICBT materials and protocol based on Stage I Phase I findings (Stage I Phase II).
-Based on experience and lessons learned in Stage I Phase I, the investigators will refine and improve the ICBT approach and study methods for teh Stage I Phase III randomized pilot trial.
Aim 3: To conduct a randomized controlled pilot trial comparing ICBT plus standard Substance Abuse Treatment Program (SATP) or PTSD care versus standard SATP or PTSD care alone, with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at post treatment and 3-month post treatment follow-up (Stage I Phase III: Randomized Pilot Trial).
Potential subjects will be receiving PTSD or substance use treatment services at the Providence Veterans Affairs Medical Center (PVAMC), and will be referred by clinicians in these respective clinics for participation in the study. Patients will be approached by the clinic staff about potential interest in the study. If they wish to learn more about the study, the research coordinator (an on-site employee) is contacted, a suitable time arranged, and the patient is engaged in the process of informed consent.
If consent is granted, the subjects completes the baseline assessment. The baseline assessment consists of measures gathered via interview by a member of the research team, self-administered surveys completed directly by the subject, and review of the subject's medical record to extract demographic, substance use, and treatment history information, as well as chart diagnoses.
The interview portion of the assessment consists of:
The self-administered portion of the assessment consists of measures designed to assess:
If the subject continues to meet criteria for PTSD (i.e. the CAPS interview confirms diagnosis of DSM-IV PTSD, with symptom severity at 44 or higher), he or she is eligible to participate. For Stage I Phase I, the patient would receive the ICBT therapy. For Stage I Phase III, the patient would be randomized to receive either the ICBT therapy plus standard treatment, or standard treatment only.
Research assessments are then also conducted at three months and six months post baseline assessment. This follow-up assessment will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to enroll approximately 16 subjects in the Stage I Phase I and to randomize approximately 64 subjects in the Stage I Phase III of the study. The subject outcome and program experiences with the protocol will be used in planning the subsequent federal grant application for a randomized controlled trial.
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56 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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